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Office of Policy for Pharmaceutical Quality, OPQ, CDER. Vinayak Pawar Good Manufacturing Practice. (CGMP) for manufacture of drugs. No distinction between API, excipients and finished pharmaceuticals. ? CGMP regulations - Agency's interpretation of .. science, (process) control systems engineering and quality.
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110. Advanced Pharmaceutical Solids, Jens T. Carstensen. 111. Endotoxins: Pyrogens, LAL Testing, and Depyrogenation, Second. Edition, Revised and Expanded, Kevin L. Williams. 112. Pharmaceutical Process Engineering, Anthony J. Hickey and David. Ganderton. 113. Pharmacogenomics, edited by Werner Kalow, Urs
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